Active substancePipemid acidPipemid acid
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  • Dosage form: & nbspCapsules.
    Composition:Per one capsule
    Active substance: piperidic acid trihydrate - 236 mg (in terms of pipemidic acid) - 200 mg.
    Excipients: silicon dioxide colloid (aerosil) - 1.5 mg, magnesium stearate - 3 mg, carboxymethyl starch sodium (primogel, sodium starch glycolate) -15 mg, lactose monohydrate (sugar milk) * - 44.5 mg.
    * The amount of lactose monohydrate may vary depending on the content of the active substance in the substance of pipemidic acid trihydrate.
    Composition of gelatin capsule:
    Gelatin - up to 100%; cover: titanium dioxide - 2.1%, brilliant blue - 0.13%, yellow quinoline - 0.19%; body: titanium dioxide - 2.2%.
    Description:Hard gelatin capsules No. 1 with a white casing and a green lid. The contents of capsules - powder from white with a yellowish tinge to light yellow color, powder caking is allowed.
    Pharmacotherapeutic group:Antimicrobial agent - rchinolone.
    ATX: & nbsp

    J.01.M.B   Other quinolones

    J.01.M.B.04   Pipedic acid

    Pharmacodynamics:It belongs to the group of quinolone preparations and is used in the treatment of infections of the urinary tract caused by pathogens sensitive to pipemidic acid.
    Pipemidic acid suppresses bacterial DNA topoisomerase II, which leads to the disintegration of bacterial DNA. This effect is more pronounced with respect to microorganisms that are in the proliferation phase. High concentrations of Ipimidic acid inhibit both the synthesis of RNA and the synthesis of bacterial proteins. The drug has a bactericidal effect on most of the graphing aerobic microorganisms (Proteus vulgaris, Proteus mirabilis, Klebsiella pneumoniae, Pneudomonas aeruginosa, Escherichia coli, Neisseria spp., Etc.).
    The percentage of occurrence of resistance is from 10% (Escherichia coli, Staphylococcus aureus) to 62% (Pneudomonas aeruginosa). Gram-positive microorganisms are resistant to iipemidovon acid. Not active against anaerobes.
    Pipemidic acid creates high concentrations in the urine, the activity increases with alkalinization of urine.
    Pharmacokinetics:After oral administration, it is quickly absorbed, bioavailability is 30-60%. After ingestion at a dose of 400 mg, the maximum concentration of Ipimidic acid (3.5 μg / ml) is reached after 70-80 minutes.
    The binding to plasma proteins is approximately 30% and depends on the concentration of Ipimeidic acid in the blood serum.
    High concentrations of Ipime acid are produced in the kidneys, urine and liquid of the prostate gland. Pipemid acid, like other quinolone compounds, penetrates the placenta and in trace amounts into the mother's milk. Pipemid acid most of it is excreted from the body through the kidneys in an unchanged form. In daily urine, 50-85% of the dose administered is determined. Isolation of Ipimeidic acid is directly dependent on the clearance of creatinine. The period of excretion of the drug with a normal function of the nights is 2 hours 15 minutes, and the total clearance 6.3 ml / min. In patients with disturbed functions of the nights, slightly higher concentrations of Ipimidic acid in the blood plasma are noted than in healthy volunteers. The period of excretion from the blood plasma is somewhat elongated and is 5.7-16 hours.
    Indications:Acute and chronic infectious-inflammatory diseases of the urinary tract caused by microorganisms sensitive to pipemidic acid, including: pyelonephritis, cystitis, prostatitis.
    Contraindications:- hypersensitivity to pipemidic acid or any of the components of the drug;
    - severe violations of the liver (including cirrhosis);
    - severe disorders of kidney function (creatinine clearance (CC) <10 ml / min;
    - diseases of the central nervous system (epilepsy and other neurological conditions with a lowered convulsive threshold);
    - porphyria;
    - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
    - allergic reactions to quinolones in the anamnesis;
    - pregnancy and the period of breastfeeding;
    - Children's age under 18 years (the period of formation and growth of the skeleton).
    Carefully:- Patients with renal insufficiency (CC> 10 and <30 ml / min);
    - Old age (over 70 years);
    - impaired cerebral circulation;
    - deficiency of glucose-6-phosphate dehydrogenase.
    Pregnancy and lactation:The use of the drug during pregnancy is contraindicated.
    Pipemidic acid is excreted in breast milk, so when prescribing the drug during lactation, breastfeeding should be discontinued.
    Dosing and Administration:Inside.
    The average daily dose is 800 mg, divided into 2 receptions, i.e. 400 mg (2 capsules) every 12 hours, morning and evening before meals, with water.
    The course of treatment is an average of 10 days. If necessary, the course of treatment can be extended depending on the course of the disease, for no more than up to 4 weeks.
    Treatment of cystitis in women lasts 3 days. In patients with severe renal failure (CC> 10 and <30 ml / min), the dose should be reduced. In elderly patients with normal renal function, as well as patients with hepatic insufficiency of mild and moderate severity, dose adjustment is not required.
    During therapy, the patient is recommended to drink abundantly.
    Side effects:From the digestive system: nausea, vomiting, diarrhea, pseudomembranous colitis, gastralegia of anorexia, heartburn, bloating or abdominal pain, constipation.
    From the nervous system: impaired vision, vertigo, headache, agitation, depression, confusion, hallucinations, tremor, prolonged convulsions associated with cerebral edema, sleep disorders, sensory disturbances.
    From the skin: itching, rash, photosensitization with erythema, toxic epidermal necrolysis.
    Laboratory indicators: hemolytic anemia (in patients with deficiency of glucose-6-phosphate dehydrogenase), eosinophilia, reversible thrombocytopenia (in elderly patients and in patients with renal insufficiency).
    Other: superinfection, acute arthropathy, tendonitis.
    Overdose:There are no reports of death or the occurrence of life-threatening side effects due to an overdose of the drug. There is no specific antidote.
    Symptoms: nausea, vomiting, dizziness, headache, confusion, tremor, convulsions.
    Treatment: gastric lavage after a recent intake (less than 4 hours), activated charcoal intake, forced diuresis, hemodialysis, with the appearance of side effects from the nervous system (including epileptic convulsions) prescribe symptomatic therapydiazepam).
    In case of an overdose, the patient should be under the supervision of a doctor.
    Interaction:Pipemid acid causes the inhibition of the enzyme P450, in connection with which, while using with pipemidovoy acid slows the metabolism of theophylline and caffeine. The half-life of theophylline increases with the simultaneous use of pipemidic acid, its concentration in the serum increases by 40-80%. It is necessary to monitor the concentration of theophylline in the blood plasma during the use of pipemidic acid.Against the background of the use of pipemidic acid, as well as other antibiotics of the quinolone series, there is an increase in the concentration of caffeine in the blood serum (by 2-4 times).
    Antacids and sucralfate significantly slow the absorption of pipemidic acid. The interval between taking these drugs should be at least 2-3 hours. At the same time, no similar effect was observed with the simultaneous use of cimetidine and ranitidine.
    Pipemidic acid can enhance the anticoagulant effect of warfarin when taken concomitantly. When used simultaneously with non-steroidal anti-inflammatory drugs, seizures may occur.
    When combined with aminoglycosides, synergism is observed with respect to bactericidal action.
    Special instructions:Side effects in most cases are mild and transient, as a rule, do not require discontinuation of the drug. When allergic reactions to the drug appear, it is necessary to stop using it.
    In the treatment should avoid ultraviolet radiation due to the high risk of photosensitization. In patients with insufficiency of glucose-6-phosphate dehydrohease, hemolytic anemia can develop.
    With prolonged use of the drug should monitor the overall blood count, determine the liver and kidney function and repeat the definition of the sensitivity of microflora to the drug.
    During the course of treatment, it is necessary to increase the amount of fluid consumed (under the control of diuresis).
    Precautions should be taken for patients older than 70 years (due to an increased incidence of side effects in the elderly) and patients with impaired renal function (CC> 10 and <30 ml / min) (contraindicated in oliguria and anuria, CC <10 ml / min), dose adjustment and regular monitoring of the patient's condition are required. Be careful when prescribing patients who have a history of cerebral circulation (including cerebral hemorrhage, cerebral vasospasms), and convulsions.
    There may be a false positive reaction to urine glucose when using a Benedict reagent or a Felling solution. It is recommended to use enzymatic reactions with glucose oxidase.
    Effect on the ability to drive transp. cf. and fur:During treatment, the patient should refrain from engaging in potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Capsules 200 mg.
    Packaging:For 10 capsules in a planar cell packaging from a polyvinylchloride film and aluminum foil printed lacquered.
    For 40, 60, 80 capsules in polymer cans.
    Free space in the banks in the absence of a seal plugs filled with cotton wool medical hygroscopic.
    Each bank or 1, 2, 4, 6, 8 contour squares with instructions for use in a pack of cardboard.
    Storage conditions:In the dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.
    Shelf life:3 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003312
    Date of registration:16.11.2015
    Expiration Date:16.11.2020
    The owner of the registration certificate:VELFARM, LLC VELFARM, LLC Republic of San Marino
    Manufacturer: & nbsp
    Information update date: & nbsp2016-12-16
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